Table 5.
Pooled analysis: treatment-emergent ocular adverse events (AEs) in ≥1% of all treated eyesa in any treatment group (safety population)27
| Besifloxacin (n = 1810) n (%) | Vehicle (n = 961) n (%) | Vigamox (n = 855) n (%) | P valueb | |
|---|---|---|---|---|
| Total no of ocular AEs | 327 | 258 | 153 | |
| Eyes with ≥1 AE | 249 (13.8) | 190 (19.8) | 120 (14.0) | <0.0001 |
| Conjunctivitis | 47 (2.6) | 41 (4.3) | 33 (3.9) | 0.0223 |
| Vision blurred | 38 (2.1) | 39 (4.1) | 4 (0.5) | 0.0035 |
| Conjunctivitis, bacterial | 32 (1.8) | 27 (2.8) | 22 (2.6) | 0.0736 |
| Eye irritation | 26 (1.4) | 27 (2.8) | 12 (1.4) | 0.0187 |
| Eye pain | 28 (1.5) | 17 (1.8) | 9 (1.1) | 0.6396 |
| Eye pruritus | 18 (1.0) | 18 (1.9) | 3 (0.4) | 0.0761 |
a
Treated eyes, including study and fellow eyes;
b
P values for besifloxacin compared with vehicle (Fisher’s exact test).